WILMINGTON, Del--Zeneca Pharmaceutical's Casodex (bicaluta-mide), a new nonsteroidal antiandrogen, has received FDA approval for the hormonal treatment of advanced prostate cancer in combination with a luteinizing-hormone-releasing hormone analog (LHRH-A). The agent acts by binding to cytosol androgen receptors.
WILMINGTON, Del--Zeneca Pharmaceutical's Casodex (bicaluta-mide),a new nonsteroidal antiandrogen, has received FDA approval forthe hormonal treatment of advanced prostate cancer in combinationwith a luteinizing-hormone-releasing hormone analog (LHRH-A).The agent acts by binding to cytosol androgen receptors.
Casodex, available as 50-mg tablets, has the convenience of onetablet, once daily dosing, the company said.
In a large multicenter, double-blind, controlled clinical trial,813 patients with previously untreated advanced prostate cancerwere randomized to receive Casodex, 50 mg once daily, or flutamide(Eulexin), 250 mg three times daily, each in combination withan LHRH-A. At a median follow-up of 95 weeks, time to treatmentfailure with use of Casodex/LHRH-A therapy was similar to thatof flutamide/LHRH-A therapy.
At the same timepoint, 130 patients (32%) treated with the Casodexcombination and 145 (35%) treated with the flutamide combinationhad died. Assessment of quality of life questionnaires indicatedno significant differences between the two treatment groups.
In this study, the most frequent adverse experience with Casodexwas hot flashes (49%). Diarrhea was the adverse event most frequentlyleading to treatment withdrawal: 6% of patients treated with flutamide/LHRH-Aand 0.5% of patients treated with Casodex/LHRH-A. Of those onCasodex, 10% reported diarrhea, compared with 24% on flutamide.
Other adverse effects of Casodex included pain (general) (27%),back pain (15%), asthenia (15%), pelvic pain (13%), infection(10%), constipation (17%), and nausea (11%).
"I believe it's important to give prostate cancer patientsa choice of treatments," said Gerald W. Chodak, MD, codirector,Urologic Oncology, University of Chicago Hospitals and Clinics,and an investigator in the Casodex clinical trials. "Theavailability of Casodex means that patients choosing combinationdrug therapy can lower the chances that they will have diarrheaas a side effect of the antiandrogen," he said.